Federal health officials in the United States have unveiled significant changes to Medicare and health policy that will affect various aspects of healthcare coverage starting January 1, 2026. The Centers for Medicare & Medicaid Services (CMS) introduced updated Local Coverage Determinations for skin substitute grafts and cellular and tissue-based products, specifically targeting treatments for diabetic foot ulcers and venous leg ulcers. This decision follows a review of clinical evidence for 66 products, resulting in the inclusion of 18 items, including Grafix Prime, which gained approval following a recent randomized controlled trial.
Under these new policies, products lacking sufficient evidence for efficacy will not be covered, while others will enter a 12-month “status quo” category, allowing continued payment as further research is conducted. CMS emphasized that this approach aims to balance patient access to necessary treatments with evidence-based standards, reducing potential market disruptions while clarifying expected outcomes.
Policy Changes in Pediatric Care and Chronic Disease Management
In addition to the coverage updates, CMS plans to restrict hospitals participating in Medicare and Medicaid from performing sex-rejecting procedures on minors under the age of 18. This move follows an executive order aimed at halting practices viewed as potentially causing irreversible harm. The proposal extends to Medicaid and the Children’s Health Insurance Program, indicating a significant shift in pediatric healthcare policy across nearly all U.S. hospitals.
Moreover, CMS introduced the ACCESS model, a voluntary program set to launch in July 2026. This initiative will focus on chronic care management for conditions such as diabetes, hypertension, chronic pain, and depression. Organizations involved will receive predictable payments based on measurable health outcomes rather than the volume of services provided. This model is designed to enhance access to digital tools, remote monitoring, and technology-supported care for individuals enrolled in Original Medicare, while simultaneously offering clinicians the flexibility to innovate and reduce healthcare costs.
Enhancements to Price Transparency and Healthcare Accessibility
CMS is also collaborating with the Departments of Labor and Treasury to propose substantial updates to federal healthcare price transparency rules first enacted in 2020. The anticipated changes aim to streamline pricing data, making it more comprehensible for consumers by reducing duplicative information and lowering reporting thresholds for out-of-network prices. The reporting frequency will shift from monthly to quarterly, and new mandates will ensure that cost-sharing information is readily available both online and via phone, thereby aligning transparency regulations with consumer protections under the No Surprises Act.
These combined initiatives reflect a concerted effort by federal officials to modernize Medicare and the overall healthcare system. By tightening evidence standards, enhancing oversight, and expanding access to technology-supported care, CMS aims to make healthcare pricing more understandable for average Americans while ensuring that patients receive the quality care they deserve.
